Table 3. Adverse events considered related to study treatment (CDX-1401, resiquimod, and/or poly-ICLC).
Table includes all adverse events reported with a possible, probable, or definite relationship to any of the study treatments, occurring in more than one patient. No grade 3, 4, or 5 events have been reported as potentially related to study treatment.
| CDX-1401plus topical resiquimod (cohorts 1–3; n = 23), n (%) | CDX-1401 plus poly-ICLC (cohort 4; n = 7), n (%) | CDX-1401 plus subcutaneous resiquimod (cohort 5; n = 7), n (%) | CDX-1401 plus poly-ICLC and subcutaneous resiquimod (cohort 6; n = 8), n (%) | |
|---|---|---|---|---|
| Administration site reaction | 18 (78) | 5 (71) | 5 (71) | 7 (88) |
| Fatigue | 5 (22) | 3 (43) | 2 (29) | 1 (13) |
| Nausea | 2 (9) | 0 (0) | 0 (0) | 2 (25) |
| Chills | 1 (4) | 1 (14) | 0 (0) | 2 (25) |
| Influenza-like illness | 2 (9) | 1 (14) | 0 (0) | 0 (0) |
| Decreased appetite | 3 (13) | 0 (0) | 0 (0) | 0 (0) |
| Arthralgia | 2 (9) | 0 (0) | 0 (0) | 1 (13) |
| Myalgia | 0 (0) | 0 (0) | 2 (29) | 1 (13) |
| Pyrexia | 1 (4) | 1 (14) | 0 (0) | 0 (0) |
| Hemoglobin decreased | 2 (9) | 0 (0) | 0 (0) | 0 (0) |
| Dizziness | 1 (4) | 0 (0) | 0 (0) | 1 (13) |